Paxil and Other Drugs to Get Labeling Change

Rockville, MDThe FDA has determined that current labeling for drugs like Paxil is too confusing. The organization has now proposed a change to drug labeling to make it more clear which drugs are safe for women who are pregnant and/or breastfeeding. Although the move will likely help many women in the future, it comes too late for those who took Paxil and other SSRIs while pregnant.

Currently, drugs are classed by a code that shows how safe they are for pregnant and breastfeeding women. Category A drugs are considered safe to take while Category X drugs have been shown to cause harm to human fetuses. Categories B, C and D fall in between the two extremes.

The FDA would like to see the codes replaced with sections in each drug's label that clearly describes the risk to the fetus. According to the FDA, the new labeling would have three sections. The first section, called the "Fetal Risk Summary," would contain information about the known effects of the drug on the fetus and whether this risk is based on human or animal trials.

The second section, called "Clinical Considerations," would include information about what effects the drug might have on a woman or fetus before the woman knows she is pregnant. The section would also include important information concerning dosing and addressing complications.

The third section, called "Data," would give more detail about the data that was used in developing the "Fetal Risk Summary." The new labeling is specifically directed to health care professionals, but could be adapted for package inserts or medication guides.

The hope is that the new labels would make the risks associated with different drugs less ambiguous. For example, under current labeling a drug may be dangerous in the first trimester but safe in the third trimester and still receive a Category X classification.

Although the move will likely help millions of women determine which drugs they should and should not take while pregnant, it comes far too late for many women who took Paxil and other SSRIs (selective serotonin reuptake inhibitors) while they were pregnant. These women later learned had a much higher risk of having babies with heart defects than women who took other antidepressants. Such birth defects include holes and malformations in the heart's chambers.

Another, serious side effect of taking SSRIs while pregnant is persistent pulmonary hypertension of the newborn (PPHN—formerly known as primary pulmonary hypertension of the newborn). PPHN is a potentially fatal birth defect in which the baby's blood flow bypasses the lungs and is therefore very low in oxygen. The condition puts a great deal of stress on the baby's other organs.

Many women know the pain of having a baby born with birth defects. Some babies have survived, but they may face a lifetime of surgeries and medical problems. Other infants have not survived. In both cases, the families of the babies are investigating lawsuits against the maker of Paxil and other SSRIs alleging they were not adequately warned about the risk their babies were exposed to.

If you or someone you love took Paxil or other SSRIs while pregnant, contact a lawyer to discuss your legal options.